Memory Gel Breast Implant: What is it and Is it Safe to Use?
People use breast implants to augment their breast size. Some even use them to reconstruct their breasts after a mastectomy (the surgical removal of one breast or both). You can even use breast implants to correct congenital anomalies. As such, we can refer to breast implants as medical devices. Breast implants are made up of two parts. The first part is an outer shell made of silicone. The second part is the filler, which could either be saline or silicone gel. There are other types of fillers but these two are the most commonly used. One popular type of silicone implants is the memory gel breast implants. There have been lots of talks on this brand. What is this brand all about? Is it safe to use?
Come to think of it, about 5-10 million women all over the world have implants in their breasts. In the year 2010 alone, 296,203 breasts were surgically augmented in the US. That same year, there were 93,083 breast reconstructions. That makes a total of about 400,000 procedures. About half of this number made use of silicone gel implants. One of the two brands of silicone implants that got FDA approval in 2006 is the Memory Gel. Let’s find out how safe it is to use this brand of silicone implants.
Is It Safe to Use Memory Gel Breast Implants?
After giving its approval to Memory Gel in 2006, the FDA asked the company to conduct studies after this approval to evaluate the long-term safety and performance of its product. This was part of the conditions for approval.
In 2011, there was an update from the FDA the Safety of Memory Gel, and the other brand that was approved in 2006. This update was a result of facts and evidence.
In the long run, the FDA says it has every reason to believe that silicone implants have considerable safety assurance. They deem them to be effective when people use them, strictly following label instructions.
There are a few common adverse outcomes and local complications. However, these are risks that you would be aware of before you accept to use the implants. Usually, the doctor would explain the risks and benefits of the implants to you before you agree to use it.
So then, if the doctor already told you about the risk, you would have to make an informed decision. Nobody should use Memory gel implants, or any breast implant for that matter, without being adequately informed of the risks and benefits involved.
Anyways, the FDA concluded that the more time the implants spend in your breasts, the higher your chances of experiencing adverse outcomes and local complications. This means that with each year that passes by, your risks increase when you have Memory Gel implants.
So then, if you are going to use these implants, you should monitor your breasts for any local complications. Do this as long as you still have the implants in your breasts.
Some of the most common complications that people may experience with Memory Gel implants include wrinkling, implant rupture, asymmetry, capsular contracture, and pain. These are not different from the general risks of having implants.
The major concern of most people with silicone implants is the risk of having a silent rupture. But then, MRI screening can help detect most of these silent ruptures. You should do them routinely as per your doctor’s instructions.
There seems to be no apparent link between having Memory Gel implants and risks for breast and reproductive problems. So then, they are generally safe.
Are There Any Concerns?
Yes, there are quite a few concerns about Memory Gel implants. But let’s have a general overview first.
In the year 2015, there were about 16 million cosmetic surgeries in the U.S alone. These include rhinoplasties, liposuction, and of course, breast augmentations.
With how easy it is to get plastic surgeries nowadays, just about anybody can change anything she dislikes about her body. Many of these people end up with little to no complications.
But then, not everyone is that lucky. Some women who get implants experience complications, which can be very severe in some cases. Although serious adverse effects are very rare, they sometimes do occur.
Just like any other implant, some women who got Memory Gel have experienced complications, as well as illness. Some of these consumers have even initiated lawsuits against the producers of Memory Gel, Mentor Worldwide LLC.
In February of 2017, a woman sued the company in Los Angeles for negligence and manufacturing defects, among a few other complaints. And in March of 2019, the FDA sent a warning letter to the manufacturers for not fulfilling their post-approval requirements.
Remember that the company was to carry out post-approval studies on the long-term safety of their implants. FDA says the companies have fallen short in that requirement. So they sent them a warning letter.
Why is the post-approval study very important? It is important because the company is supposed to follow up on their consumers. They would get regular feedbacks from the consumers to assess the safety of the product for 10 years.
According to the FDA, The producers of Memory Gel need to do their post-market studies to evaluate and affirm the safety of their Memory Gel implants.
Anyways, the company has issued an official statement on their website to say that its post-approval study is set to begin in earnest. They say the study would include about 43,000 women. They say it would be one of the most extensive post-market studies for any device in the history of the United States.
How Will You Know If There Is a Problem?
What if there is a problem with your implant, how would you know? Generally speaking, many of these problems have clear-cut symptoms. So you will know that something is wrong.
But then, there is the risk of silent rupture, which may occur with no symptoms whatsoever. Skilled plastic surgeons typically detect only 30 percent of silicone implant ruptures. But then, MRI scans can detect about 80 percent or more.
So then, the important thing, if you have a Memory Gel breast implant, is to go for routine MRI screenings. Your plastic surgeon will talk to you about this when you opt to get the implants. So long as you follow all the instructions, you should be safe.